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Title 21 Part 880 → Subpart G → §880.6350

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6350

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6350

e-CFR data is current as of July 22, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6350


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6350   Battery-powered medical examination light.

(a) Identification. A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]